Devices › Detector and alarm, arrhythmia
Device brand name · Implantable loop recorder
Reveal Dx: medical device reports filed with FDA
730 reports name it, 2010–2021. Manufacturer given most often on reports: Medtronic Med Rel. Product code DSI.
- 730
- device reports naming the brand
- 0% of all MAUDE reports · about 44 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 62.3%
- classified as malfunction
- 90.5% across the product code
- 0.4%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 730 reports that name the brand "Reveal Dx" (implantable loop recorder), received between February 2010 and June 2021; the manufacturer given most often on reports is Medtronic Med Rel. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (62.3%), injury (37.3%) and death (0.4%); across all detector and alarm, arrhythmia reports (product code DSI) death is recorded in 1.5% and malfunction in 90.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are under-sensing (26%), over-sensing (18.2%) and device remains activated (12.5%). The patient problems coded most often are pain, failure of implant and cardiac arrest. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Reveal Dx was received in the five years to August 2026; the latest was received in June 2021.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 33,398 reports carrying product code DSI. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Under-sensing | 190 | 26% | 23.7% |
| Over-sensing | 133 | 18.2% | 15.6% |
| Device remains activated | 91 | 12.5% | 0.5% |
| Signal artifact/noise | 91 | 12.5% | 5.6% |
| Failure to interrogate | 67 | 9.2% | 2.1% |
| Invalid sensing | 51 | 7% | 2% |
| Device sensing problem | 40 | 5.5% | 4.8% |
| Data problem | 34 | 4.7% | 0.5% |
| Insufficient device problem information | 30 | 4.1% | 0.5% |
| Communication or transmission problemthe device could not communicate or transmit | 25 | 3.4% | 3.3% |
| Failure to sense | 21 | 2.9% | 0.2% |
| Premature discharge of battery | 14 | 1.9% | 10.2% |
| Battery problema problem with the battery | 13 | 1.8% | 1.2% |
| Unable to obtain readings | 12 | 1.6% | 2.2% |
| Defective devicethe device was defective | 6 | 0.8% | 0.4% |
| Device expiration issue | 6 | 0.8% | 0.1% |
| Electromagnetic interference | 6 | 0.8% | 1.3% |
| Failure to power up | 6 | 0.8% | 0.3% |
| Migration or expulsion of device | 6 | 0.8% | 3.9% |
| Incorrect measurementthe device measured wrongly | 5 | 0.7% | 0.6% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 21 | 2.9% |
| Failure of implant | 20 | 2.7% |
| Cardiac arrestthe heart stopped | 12 | 1.6% |
| Discomfortdiscomfort | 8 | 1.1% |
| Erosion | 7 | 1% |
| Syncopefainting | 7 | 1% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 7 | 1% |
| Burning sensationa burning feeling | 6 | 0.8% |
| Pocket erosion | 6 | 0.8% |
| Bradycardiaslow heart rate | 5 | 0.7% |
| Dizzinesslight-headedness or unsteadiness | 5 | 0.7% |
| Hypersensitivity/allergic reaction | 5 | 0.7% |
| Deaththe patient died; cause not stated by this term | 4 | 0.5% |
| Fainting | 2 | 0.3% |
| Palpitationsawareness of the heartbeat | 2 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Reveal Dx | Product code DSI | All MAUDE reports |
|---|---|---|---|
| Reports | 730 | 33,398 | 26,136,888 |
| Share of that pool | — | 2.2% | 0% |
| Classified as death, per 1,000 reports | 4 | 15 | 9 |
| Classified as injury | 37.3% | 7.8% | 36.2% |
| Classified as malfunction | 62.3% | 90.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code DSI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Reveal LINQ | 19,184 | 264 | 0% |
| MX40 1.4 GHz Smart Hopping | 5,135 | 6 | 1.3% |
| Reveal Xt | 2,037 | 0 | 0.1% |
| Mx40 2 4 Ghz Smart Hopping | 785 | 0 | 1.5% |
| Acuity Central Monitoring | 710 | 0 | 0% |
| Mp70 Intellivue Patient Monitor | 682 | 0 | 15.4% |
| IntelliVue Multi Measurement Server X2 | 1,924 | 135 | 1.7% |
| Intellivue Mx40 802 11a/B/G | 329 | 0 | 3% |
| Spacelabs Ultraview Sl Command Module | 200 | 4 | 8.5% |
| IntelliVue MX800 patient monitor | 502 | 54 | 10.6% |
| Patient Connector | 207 | 83 | 0% |
| IntelliVue MX40 2.4GHz | 192 | 56 | 6.8% |
| Passport 2 Monitor | 469 | 0 | 0.2% |
| IntelliVue MP5 | 261 | 73 | 10.7% |
| Zio AT | 711 | 90 | 3.5% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Reveal Dx reports
How many FDA reports name Reveal Dx?
730 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (62.3%), injury (37.3%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
under-sensing (26%), over-sensing (18.2%), device remains activated (12.5%), signal artifact/noise (12.5%) and failure to interrogate (9.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Reveal Dx was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.